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Beverage Consumption and Fine Motor Control (LCS)

Primary Purpose

Body Weight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beverage
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Body Weight focused on measuring energy intake, energy expenditure, appetite

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI between 25-40 kg/M2
  • Non or rare users of LCS
  • Willing to consume large volumes of beverages daily

Exclusion Criteria:

  • Weight change > 3kg in the last year
  • Plan to initiate a new diet plan in the next 6 months
  • Exhibit eating restraint
  • Pregnant/lactating

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Sucrose Sweetened Beverage

Aspartame Sweetened Beverage

Saccharin Sweetened Beverage

Sucralose Sweetened Beverage

Rebaudioside A Sweeteened Beverage

Arm Description

100-140 g sucrose/day

0.541-0.757 g aspartame Sweetened Beverage/day

0.300-0.455 g saccharin Sweetened Beverage/day

0.167-0.233 g sucralose Sweetened Beverage/day

0.250-0.350 g rebaudioside A Sweetened Beverage/day

Outcomes

Primary Outcome Measures

Body Weight
Body Composition
Duel emission X-ray absorbtiometry
Energy Intake
24 hr Dietary Recall
Appetite
24 hr visual analog scale appetite
Energy Expenditure
accelerometer

Secondary Outcome Measures

Full Information

First Posted
October 5, 2016
Last Updated
March 19, 2019
Sponsor
Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT02928653
Brief Title
Beverage Consumption and Fine Motor Control
Acronym
LCS
Official Title
The Effect of Low Calorie Sweetener Consumption on Body Weight, Body Composition, Appetite, and Energy Intake
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study will be to compare the effects of daily consumption of aspartame, rebaudioside a, saccharin, sucralose, and sucrose on body weight and composition in a standardized protocol. The investigators hypothesize that individual low calorie sweeteners (consumed in a beverage) differ from each other in promoting weight loss and decreased fat mass (without energy restriction or dietary guidance) based on their chemical structure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight
Keywords
energy intake, energy expenditure, appetite

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sucrose Sweetened Beverage
Arm Type
Active Comparator
Arm Description
100-140 g sucrose/day
Arm Title
Aspartame Sweetened Beverage
Arm Type
Experimental
Arm Description
0.541-0.757 g aspartame Sweetened Beverage/day
Arm Title
Saccharin Sweetened Beverage
Arm Type
Experimental
Arm Description
0.300-0.455 g saccharin Sweetened Beverage/day
Arm Title
Sucralose Sweetened Beverage
Arm Type
Experimental
Arm Description
0.167-0.233 g sucralose Sweetened Beverage/day
Arm Title
Rebaudioside A Sweeteened Beverage
Arm Type
Experimental
Arm Description
0.250-0.350 g rebaudioside A Sweetened Beverage/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Beverage
Intervention Description
Participants will receive 1.25 - 1.75 L of sweetened beverage a day for 12 weeks
Primary Outcome Measure Information:
Title
Body Weight
Time Frame
12 weeks
Title
Body Composition
Description
Duel emission X-ray absorbtiometry
Time Frame
12 weeks
Title
Energy Intake
Description
24 hr Dietary Recall
Time Frame
12 weeks
Title
Appetite
Description
24 hr visual analog scale appetite
Time Frame
12 weeks
Title
Energy Expenditure
Description
accelerometer
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI between 25-40 kg/M2 Non or rare users of LCS Willing to consume large volumes of beverages daily Exclusion Criteria: Weight change > 3kg in the last year Plan to initiate a new diet plan in the next 6 months Exhibit eating restraint Pregnant/lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D Mattes, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30997499
Citation
Higgins KA, Mattes RD. A randomized controlled trial contrasting the effects of 4 low-calorie sweeteners and sucrose on body weight in adults with overweight or obesity. Am J Clin Nutr. 2019 May 1;109(5):1288-1301. doi: 10.1093/ajcn/nqy381.
Results Reference
derived

Learn more about this trial

Beverage Consumption and Fine Motor Control

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